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  • Transcatheter Aortic Valve Implantation
  • Procedure & Performance
  • Clinical Evidence
  • Treating ssAS
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    • Overview

    For small annulus† patients, the SMART Trial data are clear: Evolut™ transcatheter aortic valve implantation (TAVI) delivers superior valve performance‡ versus SAPIEN™* TAVI with excellent patient outcomes through three years.1

    About the trial

    The SMART Trial was a prospective, multicenter, randomized controlled trial conducted to understand how valve design differences between the Medtronic self-expandable (SE) Evolut™ platform and Edwards Lifesciences balloon-expandable (BE) SAPIEN™* transcatheter aortic valve implantation system affect treatment of small aortic annulus (≤ 430 mm2) patients with symptomatic, severe native-aortic stenosis.

    The latest data reported through two years reinforce that these contemporary TAVs behave differently in this patient group, providing physicians with crucial insights to tailor treatment decisions according to individual patient needs.

    SMART Trial 3-year results

    Evolut™ TAVI continues to demonstrate superior valve performance‡ compared to SAPIEN™* TAVI and strong patient outcomes with significantly lower rates of valve thrombosis.§

    More than 1 in 2 patients† are expected to experience BVD‡

    with SAPIEN™* TAVI

    within 3 years1

    p < 0.001
     

    Evolut™ TAVI: 16.3%
    SAPIEN™* TAVI: 54.4%

    Sustained excellent patient outcomes through 3 years1

    Evolut™ TAVI: 25.4% | SAPIEN™* TAVI: 22.6% p = 0.44 | Hazard ratio, 1.13 (95% CI: 0.83, 1.53)
    Clinical outcome composite: All-cause mortality, disabling stroke, or heart failure rehospitalization

    6x more clinical valve thrombosis§

    with SAPIEN™* TAVI

    through 3 years in small annulus patients.†,1

    p = 0.008


    Evolut™ TAVI: 0.6%
    SAPIEN™* TAVI: 3.7%

    3.4x more ≥ moderate PPM

    with SAPIEN™* TAVI

    at 30 days in small annulus patients.†,◊,1

    p < 0.001


    Evolut™ TAVI: 9.9%
    SAPIEN™* TAVI: 33.2%

    202409870a_Bar Charts_3year_CMYK_Red_PPM_ALT

    Evolut™ TAVI in women

    Only Evolut™ TAVI design has superior valve performance for women compared to SAPIEN™* TAVI at one year.¶,2

    Women’s hearts are different and so is their AS journey. While women are typically underrepresented in major clinical trials,3 the SMART Trial enrolled predominantly women due to its focus on small annulus patients. The SMART Trial is the largest, randomized controlled TAVI trial to primarily enroll women — providing important clinical insights into this patient population.
     

    Drs. Sabine Bleiziffer, Renuka Jain, Roxana Mehran, and Puja Parikh examine the significant healthcare challenge that is the underdiagnosis, under-referral, and undertreatment of women with aortic stenosis.

    Read their thoughts on how we address this, what role the heart team plays, and how the groundbreaking SMART Trial is making a difference.

    Check out the current supplement issue of Cardiac Interventions Today.

    Download the supplement (open in new window)

    Get additional information.

    Visit clinicaltrials.gov for more information on the SMART Trial. Use identifier number NCT04722250 to see details on the trial.

    Learn more about the trial (open in new window)

    Explore real-world data.

    The Medtronic CoreValve™/Evolut™ platform is supported by a robust body of clinical evidence. Explore our evidence summaries and real-world data.

    Discover now

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